This invention relates generally to hand-portable, durable, non-rigid shipping containers and related methods of transporting, particularly containers and methods suitable for transporting relatively small sizes or quantities of hazardous items such as medical diagnostic specimens, biological materials, and infectious substances by conventional private or public carriers.
Something removed from a human or other animal may need to be transferred from the place of extraction to a place where it can be analyzed. For example, a surgically removed hip prosthesis may need to be returned to the manufacturer for analysis or it may need to be sent to a laboratory where human tissue on the prosthesis is to be analyzed. When the sending and receiving places are distant, the substance may need to be shipped via a private or public carrier. Such transportation can be via land (road or rail), sea or air (passenger or cargo craft).
It will be readily appreciated that shipping such a specimen poses a significant health risk if the specimen contains an infectious or potentially infectious substance and it is not adequately packaged. There are many regulations, from local governmental to international regulations, seeking to define safe shipping standards. Pertinent federal regulations in the United States include those set forth in titles 29, 39, 42 and 49 of the Code of Federal Regulations. Examples of particular agencies concerned with safe packaging and shipping standards are the International Civil Aviation Organization/International Air Transport Association (ICAO/IATA), United States Department of Transportation (DOT), U.S. Center of Disease Control (CDC), U.S. Occupational Safety and Health Administration (OSHA), United Nations (UN), and World Health Organization (WHO). Specific pertinent standards include:
1. Dangerous Goods Regulations International Air Transport Association 38th Edition, Jan. 1, 1997 PA1 2. Code of Federal Regulations (CFR) Title 49--Transportation Subtitle B--Other Regulations Relating to Transportation U.S. Dept. of Transportation Parts 172, 173, 176 and 178 Oct. 1, 1996 PA1 3. Biosafety in Microbiological and Biomedical Laboratories U.S. Dept. of Health and Human Services Public Health Service (CDC and NIH) 3rd Edition May, 1993 PA1 4. Code of Federal Regulations (CFR) Title 42--Public Health U.S. Dept. of Health and Human Services Part 72 Interstate Shipment of Etiologic Agents Mar. 2, 1995 PA1 5. Hazardous Material Regulations Transportation Safety Act of 1974 Consolidation of 1976 Pocket Guide, 1991 PA1 6. U.S. Dept. of Health and Human Services Center for Devices and Radiological Health (CDRH) U.S. Food and Drug Administration (FDA) Generic Standard Operating Procedure "Handling, Packaging, Transportation, Storage and Sterilization of Medical Devices". PA1 7. U.S. Dept. of Health and Human Services Occupational Safety and Health Administration (OSHA) Section 3--Final Rules on Occupational Exposure to Bloodborne Pathogens PA1 8. American Society for Testing and Materials (ASTM) Proposed Documents for ISO/TC 150/WG5 "Retrieval and Analysis of Implantable Medical Devices" PA1 9. United Nations Documents Requirements for Transportation of Hazardous Goods
October, 1994
In trying to transport hazardous items in compliance with the foregoing, problems can arise with existing containers with regard to durability, rigidity, size, weight, cost, reusability, and cost of refurbishment. These issues are especially significant when the containers are required to be leakproof and pressure resistant. Durability problems exist with rigid containers due to the inevitable bangs, scrapes, dents and other permanent distortions that can occur in containers during handling and transport. Durability can also be adversely affected by external environmental conditions. These potential problems can bring about a loss of integrity in the container. In some cases, a container cannot be reused due to its lack of durability or because it was designed for one use only. If the container is reusable, it may have to undergo an expensive process to refurbish the container for reuse in order to meet original specifications, performance criteria and regulations. Another problem that exists is that performance certified containers can be very large in comparison to the material or specimens to be transported, thereby creating unnecessary cost of the container and increased cost of transportation. Also, the lack of ability to match a performance oriented container size to the size of the materials/specimen can cause the transport to be unwieldy, heavier than necessary, difficult to store and too large for its intended purpose. Furthermore, there are containers which do not even meet the criteria of performance testing for hazardous materials.
In view of the foregoing, there is a particular need for a shipping container and related method which can transport hazardous items that are in the solid or solid plus liquid forms and that have irregular shapes, odd size dimensions or are cumbersome. Such a container and method preferably should meet both general and specific requirements and testing protocols of national and international regulations for modes of transportation to include air, sea, rail and highway. Such a container should be durable, lightweight, flexible and reusable. The foregoing especially includes the capability of transporting hazardous items in a leakproof, pressure resistant, vibration resistant container that meets all applicable criteria. Types of substances which such a container and method should accommodate include, but are not limited to, pathogens, bacteria, blood, modified organisms, contaminants, infectious substances, compounds, chemicals, toxins and vaccines.